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Holter Recorders

Holter or Ambulatory ECG Monitoring       Ambulatory electrocardiography recorders are called “Holter” recorders, so named after Dr. Norman Holter. The Holter monitor is a type of portable electrocardiogram (ECG). It records the electrical...

FDA 510K

It is important to note that the US FDA is undergoing a major change that will affect the entire US regulatory process. Called “Case for Quality” or CFQ. To understand CFQ, it is best to first understand the current process. The FDA “510K”...